Multifocal Intraocular Lens x Monovision x Hybrid Monovision After Bilateral Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract; Presbyopia
• Interventions: Procedure: Cataract surgery with intraocular lens implantation.

• Registration Number: NCT02595177
• Lead Sponsor: Federal University of São Paulo

Brief Summary

To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.

Detailed Description

The purpose of this study is to evaluate the results in randomized patients that receive bilateral multifocal IOLs, monofocal IOLs with monovision with emmetropia in one eye and 1.50 D of myopia in the other eye, or monofocal IOL in the dominant eye and multifocal IOL in the non-dominant eye, then evaluate visual and refractive outcomes, as well as independence for glasses after bilateral surgery with 1 year of follow up.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-10-27
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-01
• Last Update Submitted: 2015-11-01
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Bilateral senile cataracts.
• Implantation of IOL in the capsular bag;
• Implants from 10-30 diopter;
• Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery;

Exclusion Criteria

• Amblyopia;
• Single Eye;
• History of intraocular surgery in the previous year;
• Sequel to prior ocular trauma;
• Important Microphthalmia or aniridia;
• History of damage to the corneal endothelium (chemical burns, herpetic keratitis, corneal guttata);
• Corneal astigmatism > 1.0 D;
• IOP ≥ 21 mmHg in standard caliper;
• Ocular pathology that affects visual function (uveitis, diabetic retinopathy, age-related macular degeneration, macular dystrophy, retinal detachment, glaucoma, optic neuropathy);
• Pupil > 5 mm or < 2 mm under photopic conditions;
• Asymmetrical pupils in the eye or between the eyes;
• Binocular vision absence;
• Any situation that endangers the implant position in the capsular bag (post-traumatic zonular weakness, pseudoexfoliation, for example);
• Patient probably need to laser treatment of the retina;
• Patients whose expectations are unrealistic;
• Patients whose lifestyle involves high expectations of visual acuity (writer, driver, for example);
• Patients at risk of not meeting the clinical follow-up requirements (distance of travel difficulties, for example);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multifocal IOL	Cataract surgery with intraocular lens implantation.	Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, multifocal intraocular lens implantation in both eyes planning for emmetropia complete the intervention.
Hybrid Monovision	Cataract surgery with intraocular lens implantation.	Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation in the dominant eye and a multifocal IOL in the non-dominant eye complete the intervention.
Monovision	Cataract surgery with intraocular lens implantation.	Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation planning for emmetropia in one eye (dominant) and a monofocal IOL planning for 1.50 D of myopia in the other eye (non-dominant) complete the intervention.

Primary Outcome Measures

Name	Time	Method
Visual acuity	1 year	Binocular visual acuity in a semi-darkened room without correction to far, intermediate and near using a typical Snellen chart that is frequently used for visual acuity testing.

Secondary Outcome Measures

Name	Time	Method
Near stereopsis measure	1 year	Calculate stereopsis in each group and compare them. Stereoacuity is measured using a stereogram in which separate panels are shown to each eye.
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire	1 year
Contrast sensitivity measure	1 year	Comparison between groups of the contrast sensitivity. Contrast sensitivity function at five spatial frequencies is measured with the validated instrument (Functional Vision Analyzer® (Stereo Optical, Chicago, IL, USA) with best refraction.
Speed reading measure	1 year	Assessment is performed to measure the speed reading in each group and compare them. Then using a timer to measure how long does it take to read the page. The speed reading is measured in words per minute (WPM).

Trial Locations

Locations (1)

Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP); 🇧🇷 Sao Paulo, SP, Brazil